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Quality Assurance

Area clearance during batch/product change over in Pilot Production facility. Quality Assurance

Area clearance during batch/product change over in Pilot Production facility. Quality Assurance OBJECTIVE : To provide procedure for  Area  clearance during batch/product change over in Pilot Production facility. RESPONSIBILITY : Officer Quality Assurance  for implementation Quality Assurance Manager to ensure compliance. PROCEDURE : Note: (i)  Type-A  Area clearance : During …

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Preparation, Approval and Control of Guidelines (Quality Assurance)

Preparation, Approval and Control of Guidelines (Quality Assurance) OBJECTIVE : To lay down the procedure for the preparation, approval and control of Guidelines. RESPONSIBILITY : All the personnel shall to be familiar with this SOP. The approver to ensure that all proposed Guidelines conform to this SOP before approving any …

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Technology transfer

Technology transfer OBJECTIVE : To  lay down a procedure for technology transfer of New products . SCOPE : The scope of this SOP is to all the new Products for which Technology has been provided by outside party or from R&D. RESPONSIBILITY : Head of Production, QA Head, QC Head  …

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Correction of Documentation Errors

  Objective To lay down a procedure for correcting the errors in documentation. Scope This Standard Operating Procedure is applicable for correction of all documentation error in written procedures (SOPs, Specifications, STPs, or TDs etc.) and records (Batch Manufacturing Records, Raw Data, Log Books, etc.) Responsibility Each employee shall be …

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New Product Design and Development Process

  New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable all pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of …

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Approval of vendors (Packing Materials)

  OBJECTIVE: To lay down a procedure for approval of new vendors for packaging materials. SCOPE: This SOP is applicable to all new manufacturer / suppliers of packaging materials RESPONSIBILITY: Purchase, QC and QA personnel shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY : QA Head …

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Vendor Development and Approval (API and excipients)

Vendor Development and Approval (API and excipients) OBJECTIVE : To lay down a procedure for vendor audit for raw material, developing and approving the vendor who can consistently supply the raw materials with right quality and quantity at right time. SCOPE : This Standard Operating Procedure is applicable to approve …

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Cleaning validation

Cleaning validation OBJECTIVE : Objective of this SOP is to provide the procedure to be followed during cleaning validation. SCOPE : This SOP covers the validation of cleaning procedure for equipment used for product manufacturing in pharm, company. RESPONSIBILITY : QA officer shall be responsible for issuing & implementation of …

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PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER

PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER OBJECTIVE:To lay down a procedure for microbiological monitoring of raw water and purified water. SCOPE:This SOP shall provide the procedure for sampling and testing of raw water and purified water from all the user points and all the points across the critical functions in …

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Unit Dose Sampling Procedure for Blend Uniformity

Unit Dose Sampling Procedure for Blend Uniformity OBJECTIVE To lay down the procedure for collecting unit dose blend samples for evaluation of blend uniformity so as to ensure accurate and consistent sampling. RESPONSIBILITY : Officer – Quality Assurance to collect the samples. Head of Quality Assurance to ensure compliance. PROCEDURE: …

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